the most cost-effective, safest, and least encumbering solution to the malaria threat.1
The U.S. Army was designated by Congress (1982) as the lead agent for infectious disease research. Renewed emphasis on the importance of vaccines and other countermeasures was given in Executive Order 13139 (1999) directing that “It is the policy of the United States government to provide our military personnel with safe and effective vaccines, antidotes, and treatments that will negate or minimize the effects of these health threats.” These health threats include diseases endemic to an area of operations, such as malaria.
Under the direction of the U.S. Army Medical Research and Materiel Command (USAMRMC), the tri-service Military Infectious Diseases Research Program (MIDRP) coordinates malaria vaccine research and development at the Walter Reed Army Institute of Research (WRAIR), the Naval Medical Research Center (NMRC), and at DoD laboratories overseas in Kenya, Thailand, Indonesia, Peru, and Egypt.
The current requirements for a malaria vaccine (Appendix B) are formulated in a U.S. Army operational requirements document dated March 13, 1997, which has now expired and is due to be replaced. Although the current requirements were prepared under the auspices of the Army, the requirements are no different for the Navy and Marines. The requirements are used to guide the MIDRP Malaria Vaccine Program through the vaccine research and development process, including aiding in the decision process of when to move a product to advanced development.
The current requirements are expressed in terms of “development threshold” and “development objective,” but the consequences of a product reaching either of these benchmarks was not clear. In addition, the requirement for efficacy was subject to different interpretations since it did not distinguish between prevention of infection, clinical attacks, or severe malaria.
Rather than attempting to interpret and revise the military requirements using the same terminology as in the operational requirements